On December 14, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the closing of its previously announced public offering on a firm commitment basis of 19,161,667 shares of common stock of the Company, including the exercise in full by the underwriter of its option to purchase an additional 2,495,000 shares of common stock, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 14, 2020, View Source [SID1234576291]).

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses were approximately $86.2 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock were offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock offered has been filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 14, 2020 ADC Therapeutics SA (NYSE:ADCT) and Overland Pharmaceuticals, a fully integrated biopharmaceutical company backed by Hillhouse Capital, reported that they have jointly formed a new company, Overland ADCT BioPharma (CY) Limited, to develop and commercialize four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore (Press release, ADC Therapeutics, DEC 14, 2020, View Source [SID1234572795]). Overland Pharmaceuticals has invested $50 million in Overland ADCT BioPharma to fund operations, including development plans for approval of Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the licensed territory.

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"ADC Therapeutics’ Biologics License Application for Lonca, which was recently granted priority review status, is currently under review with the U.S. Food and Drug Administration," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "As we prepare for the potential U.S. launch of Lonca in 2021, we are delighted that Overland ADCT BioPharma will expand access to the therapy, as well as three of our other pyrrolobenzodiazepine-based ADCs, to address patient needs in greater China."

Under the terms of the agreement, ADC Therapeutics licensed exclusive development and commercialization rights to Lonca, ADCT-602, ADCT-601 and ADCT-901 for greater China and Singapore to Overland ADCT BioPharma. Overland Pharmaceuticals has invested $50 million in Overland ADCT BioPharma and Overland Pharmaceuticals will have a 51% stake and ADC Therapeutics a 49% stake. As part of the strategic business plan, Overland ADCT BioPharma may consider additional private investors and/or a potential public offering in the future. Both parties will appoint an equal number of nominees to the Board of Directors and a search is underway for a Chief Executive Officer for Overland ADCT BioPharma. ADC Therapeutics can also earn milestone payments and royalties from the regional license agreement with Overland ADCT BioPharma.

"We are pleased to work with ADC Therapeutics, a pioneer in the field of ADCs, on this strategic venture to enable the development and commercialization of multiple targeted therapies for the treatment of patients with difficult-to-treat hematological and solid tumor cancers in greater China and Singapore," said Hua Mu, MD, PhD, Co-founder of Overland Pharmaceuticals. Ed Zhang, MBA, Co-founder of Overland Pharmaceuticals, added, "Overland is committed to developing breakthrough medicines with a mission to bring innovative medicines to patients in Asia. We are excited to bring these first four candidates into the Overland ADCT BioPharma portfolio and look forward to developing this new company into a leading oncology player in greater China."

The Overland ADCT BioPharma pipeline is led by Lonca, an ADC composed of a humanized monoclonal antibody directed against human CD19. Lonca has been evaluated by ADC Therapeutics in a pivotal Phase 2 clinical trial in patients with relapsed or refractory DLBCL and is in two ongoing trials – a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma and a Phase 3 confirmatory trial in combination with rituximab in patients with relapsed or refractory DLBCL. The Overland ADCT BioPharma portfolio also includes the clinical-stage candidates ADCT-602 targeting CD22, which is currently in a Phase 1/2 clinical trial in patients with relapsed or refractory acute lymphoblastic leukemia, and ADCT-601 targeting AXL, which is currently in a Phase 1 clinical trial in patients with selected advanced solid tumors. ADCT-901 targeting KAAG1 is in preclinical development for the treatment of advanced solid tumors with high unmet medical needs.

MSQ Ventures served as an advisor to ADC Therapeutics on the China strategy and business development process.

On December 14, 2020 Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells, reported the launch, subject to market conditions, of an underwritten public offering of $100 million of its American Depositary Shares ("ADS"), each representing one ordinary share of Cellectis (Press release, Cellectis, DEC 14, 2020, View Source [SID1234572812]). In connection with the offering, Cellectis expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the aggregate offering size on the same terms and conditions.

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Citigroup, Jefferies and Barclays are acting as joint book-running managers for the offering. In addition, William Blair is acting as lead manager and Kempen & Co is acting as co-manager for the offering.

The price in dollars at which ADSs will be sold in the proposed offering, as well as the final number of ADSs will be determined by the board of directors following a bookbuilding process commencing immediately and will not be less than the volume weighted-average of the trading prices of the Company’s ordinary shares on the Euronext Growth Paris over the three trading days prior to pricing of the offering, subject to a maximum discount of 20%. The new ordinary shares underlying the ADSs will be issued through a capital increase without shareholders’ pre-emptive rights under the provisions of Article L. 225-136 of the French Commercial Code and in accordance with the delegations granted pursuant to the Resolutions 18 adopted at the combined meeting of the Company’s shareholders (Assemblée Générale Mixte) held on June 29, 2020.

The Company plans to use the net proceeds of the offering, as follows: approximately $25 million to fund the advancement of one additional UCART product candidate, approximately $20 million to pursue new human therapeutics approaches based on Cellectis’ proprietary gene editing technology outside of oncology, approximately $25 million to fund more activities in Cellectis’ proprietary state-of-the-art manufacturing facility in Raleigh, North Carolina; and the remainder for working capital and other general corporate purposes. Based on the planned use of proceeds from this offering, Cellectis believes that its cash and cash equivalents and cash flow from operations (including payments it expects to receive pursuant to collaboration agreements) as well as government funding of research programs, will be sufficient to fund Cellectis’ operations into 2023.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ American Depositary Shares was filed with the Securities and Exchange Commission (the "SEC") and has become effective. Before purchasing American Depositary Shares in the offering, you should read the preliminary prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone (888) 603-5847 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

On December 14, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), reported that it has commenced a proposed underwritten public offering, subject to market and other conditions, to issue and sell $125,000,000 of shares of its common stock (Press release, Castle Biosciences, DEC 14, 2020, View Source [SID1234572828]). In connection with the offering, Castle expects to grant the underwriters a 30-day option to purchase up to an additional $18,750,000 of shares of common stock. All of the shares in the proposed offering will be offered by Castle. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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SVB Leerink and Baird are acting as joint bookrunning managers in the proposed offering. Canaccord Genuity is acting as passive bookrunner and BTIG and Lake Street Capital Markets are acting as co-managers for the offering.

The securities described above are being offered by Castle pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Castle and became effective by rule of the Securities and Exchange Commission (the "SEC") on December 14, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, by telephone at (800) 792-2473, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 14, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca reported the initiation of TROPION-Lung01, a global pivotal phase 3 head-to-head study of datopotamab deruxtecan (Dato-DXd; DS-1062), a TROP2 directed antibody drug conjugate (ADC), versus docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations who have previously received platinum-based chemotherapy and immunotherapy (Press release, Daiichi Sankyo, DEC 14, 2020, View Source [SID1234572856]).

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Patients with advanced or metastatic NSCLC without actionable genomic alterations (such as EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET exon 14 skipping) have demonstrated an unmet need after currently approved front-line and second-line therapies are exhausted. Current treatment guidelines recommend varying combinations of platinum-based chemotherapy and/or immune checkpoint inhibitors in the front-line and second-line settings based on lung cancer subtype, immune biomarker status and other factors.1 For patients whose cancer progresses after initial treatment containing a platinum-based chemotherapy and a checkpoint inhibitor, therapeutic options are limited.1

TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in the majority of adenocarcinoma and squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.

"We recognize the need to continue to improve treatment for patients with NSCLC who are not eligible for currently approved targeted therapies, particularly those who progress following initial treatment with an immunotherapy and platinum-based chemotherapy," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "This head-to-head trial will determine whether targeting TROP2 with datopotamab deruxtecan will improve survival as compared to the standard therapy used in this setting."

"TROP2 is highly expressed in NSCLC and other cancers, making it a promising target for therapeutic development," said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. "This trial will provide an opportunity to evaluate a targeted approach with datopotamab deruxtecan, a potent ADC specifically designed to enhance selective tumor cell death, while reducing systemic exposure to chemotherapy."

TROPION-Lung01 was initiated following the encouraging clinical activity of datopotamab deruxtecan in patients with heavily pre-treated advanced NSCLC observed in the ongoing TROPION-PanTumor01 phase 1 trial, which completed enrollment of patients with lung cancer in October of 2020. Preliminary data from TROPION-PanTumor01 was recently presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (#ASCO20) and updated data will be presented at an upcoming medical meeting.

About TROPION-Lung01

This global, multicenter, randomized, open-label phase 3 trial will evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) versus docetaxel (75 mg/m2) in patients with advanced or metastatic NSCLC without actionable genomic alterations and with progression on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy received either in combination or sequentially.

Approximately 590 patients will be randomized into two arms in a 1:1 ratio to receive either datopotamab deruxtecan or docetaxel. Randomization will be stratified by histology (squamous versus nonsquamous), most immediate prior therapy and geographic region.

The primary trial endpoints are progression-free survival and overall survival. Secondary endpoints include overall response rate, duration of response, time to response, disease control rate and patient reported outcomes. Safety endpoints include treatment emergent adverse events and other safety parameters. Pharmacokinetic and immunogenicity endpoints will also be evaluated.

The study will enroll patients at sites in North America, South America, Europe and Asia. For more information visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide; there were an estimated 2.1 million new cases of lung cancer in 2018 and 1.8 million deaths.5 NSCLC accounts for 80 to 85 percent of all lung cancers.6

For patients with advanced NSCLC that do not carry actionable genomic alterations (i.e., for which no targeted therapies are approved), treatment has traditionally been limited to platinum chemotherapy.7 The introduction of immune checkpoint inhibitors in the past two decades has offered improved survival rates over traditional chemotherapy regimens, creating new options and shifting treatment to a more personalized approach for subsets of patients with NSCLC. Over the past five years, immunotherapies have become part of the treatment paradigm.7

About TROP2

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is overexpressed in many cancers.8 TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in up to 64% of adenocarcinoma and up to 75% of squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.

About Datopotamab Deruxtecan (Dato-DXd; DS-1062)

Datopotamab deruxtecan (Dato-DXd; DS-1062) is one of three lead DXd antibody drug conjugates (ADCs) in the oncology pipeline of Daiichi Sankyo.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker with a drug-to-antibody ratio (DAR) of four.

TROPION is the broad and comprehensive clinical development program to evaluate the efficacy and safety of datopotamab deruxtecan across multiple TROP2 cancers as both a monotherapy and in combination with other anticancer treatments. In addition to TROPION-Lung01, datopotamab deruxtecan is currently being evaluated in a number of clinical trials, including TROPION-Lung05, a phase 2 study in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with actionable genomic alterations previously treated with a kinase inhibitor and platinum chemotherapy and TROPION-PanTumor01, a phase 1 study in patients with advanced solid tumors that have progressed on standard treatments or for whom no standard treatment is available, which has completed enrollment of patients into a unresectable advanced NSCLC cohort and is currently enrolling patients into a triple negative breast cancer (TNBC) cohort.

Datopotamab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About the Collaboration between Daiichi Sankyo and AstraZeneca

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan (a HER2 directed ADC) in March 2019, and datopotamab deruxtecan (a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.